Saturday, February 27, 2010

Evidence based medicine: a critical appraisal

So called "evidence based medicine" has done more to harm medicine than anything else I can recall during my 30 year tenure in medicine. Doctors have become technicians, rather than practitioners following in the traditions of healers who have come before.

When I was in college, science as we know it, existed within a framework-a caste system-a pecking order. Mathematics was considered the purest science: provable with irrefutable equations. Physics took second place. It described fundamental properties of the world/universe around us, supported by mathematical equations. Chemistry followed next and then biology. The order of descent was based on how hard, irrefutable and provable the conclusions were. All science is validated by the scientific method: a theory or hypothesis is proved by well designed experiments which can be replicated in a variety of places, times and circumstances.

When I entered medicine in the 1980s, medicine was more than a job or ordinary profession. It was a commitment, a lofty avocation, a calling of sorts. (at least according to my father)--I agree. Medicine was a healing art, in the tradition of the many who had preceded us, predicated on science. It was not a science.

Sometime around 1995 the term "evidence based medicine" insinuated itself, increasingly into the verbiage of the profession. I suspect it was in large part driven by managed care companies, looking to control costs, and then, high powered medical institutions jumped onto the band-wagon, in the belief that medicine was really science, not art: throwing out the baby with the bathwater.

Properly designed controlled medical studies were carefully analyzed by statisticians. Sometimes multiple studies were combined and analyzed-- meta-analysis. Problem. Only a few potential questions were addressed. Most studies were funded, at least partly, by big Pharma, with pre-existing agendas, undoubtedly tied to feathering the pockets of CEOs and stock holders (follow the money). Medical research, by its very nature, is simplistic. In truth, it is impossible to do proper science when it comes to studying something as complicated as people. Newer studies replace and refute older ones on a regular basis. It is impossible to control the variables, many of which are unknown, poorly understood or yet to be discovered. If it takes a room of statisticians, as is frequently the case, to prove a point, it should give one pause.

The single biggest problem: data obtained from a single study is extrapolated widely, to support wide ranging conclusions, based on faulty logic superimposed on bad science.

To makes things worse, evidence, as it were, is now broken down into levels/categories-- again, a pecking order. Most in the profession have accepted this new and improved medicine without giving its precepts a second thought.

First we have placebo controlled, double blinded, randomized studies, the results of which are statistically validated and replicated in subsequent studies.Then we have non blinded controlled studies, non-controlled studies, head to head studies, published studies, clinical reports published in journals and lastly recommendations of a body of experts--my perennial favorite.

How can opinion be science?

So, let us get back to Lyme, the subject of this blog. The Klemper, Krupp and Fallon studies, are in my mind, weak science at best. They also all have somewhat different study designs and conclusions. The limitations of these studies has been discussed in detail elsewhere. The "experts" put these findings together and give us a final product: evidence based guidelines.

The better science is what physicians seem to dismiss and ignore: test tube science and other forms of "basic" science. Borrelia has been shown to convert from spirochete to cyst forms in the laboratory and back the other way. Spirochetes have been shown to exist as L-forms. Research in immunology support beliefs that infected hosts cannot be sterilized of Lyme. Human and animal models have proved that Lyme persists in the face of massive doses of antibiotics. This sort of science can control the variables. It can be replicated in multiple settings over time. The same cannot be said for clinical studies, the type of science clinical doctors rely upon, which are pooled into meta-analyses, looking for statistically significant conclusions. I could go on, write a book about this subject, with foot notes and citations. Not here.

This post is a about "evidence based medicine." In my opinion, this is a sham, a fraud. Perhaps it works for HMO physicians who are required to see patients in 6 minutes: cookbook medicine. It is not a useful tool for thoughtful, curious physicians, intent on practicing their art to the best of their ability. Patients are all different as are all physicians. Diseases are nuanced and complex.The practice of medicine is a mosaic of science, judgment, clinical experience and yes-intuition, a clinical nose, the product of years of practice.

So yes, this dumbed down version of medicine has now framed the basis for the national debate about lower cost, higher quality medicine. According to national political "experts", electronic medical records and evidenced based medicine (the mantra), will solve systemic problems with our health care system.

Who decides which evidence we use? Ivory tower physicians. Iconic figures. The Gary Wormsers of the world. Doctors for the most part, are reassured by practice guidelines: complex decisions have already been decided for them. A few other physicians, the outliers, and their demanding-annoying patients, just won't go away. It is no wonder that many readers shudder when the hear the words: evidence based medicine.

Every pre-med student is ultimately asked the question: why do you want to become a doctor. Inevitably, they all give the same, banal answer: I want to help people.

For those of us who want to be included amongst healers who use science, the state of the art as it exists at any particular point in time, as a basis, but only a starting point for the practice of their art: the art of healing; this answer turns out, in the final analysis, to not be so banal after all.

10 comments:

I think there is also a point when common sense has to prevail above all.

I currently live in a region of the country where Lyme is relatively uncommon. I am being treated by a practitioner that follows the ILADS model who is over 1,000 miles from where I live.

Physicians around here just don't see Lyme often. Hardly ever. They have no reason to be familiar with the Lyme debate, the IDSA's standard of care for Lyme, etc.

What's interesting, is that I don't often get criticized by my local physicians for my decision to continue on antibiotics, or told, "you know the Lyme is gone by now." For some reason, common sense is telling these physicians otherwise.

Why? Because I have documented proof that I was infected at one point. And I'm still sick. The medicine is helping, but slowly.

They say, "wow, I can't believe what not being diagnosed for 9 months did to you." "I really hope you are able to get this infection under control."

When facing the option of needing a local doctor to write my scripts, and asking how long she would continue writing scripts, she seemed surprised and said, "I'll treat you until you are better."

Common sense.

It seems that when physicians, people certainly educated on the merits "hard science," are not being bombarded with this study and that study, they go with common sense and their overall knowledge of the human body.

She's still producing IgM antibodies as her symptoms continue? Her body must still be fighting it. The medicine is slowly helping? Then it should be continued.

This is what frightens me the most about the current healthcare proposals...the use of evidence based medicine for determinining treatment options, insurance coverage and ultimately making unavailable any alternative treatment methods.

I wish more physicians would be on high alert to the possibilies of more restrictive care instead of "giving care to all". Not going to happen.

Thank you for writing about this! As the health care debate has continued - I shudder each time I hear about "evidence-based medicine."

When even TESTING for this disease has been manipulated so that testing positive is the equivalent of winning a perverse kind of lottery - how can the subsequent science developed by research on only those who tested unambiguously positive be trusted to be applicable to the full spectrum of lyme disease infection?

My husband was sick for 18 months before finally testing positive - improved over 30 days of IV rocephin administered by an IDSA doc. We know now we were lucky to get even that - but turned away for ANY kind of additional treatment when he began to relapse.

Luckily we found a knowledgeable doc who was willing to treat him with a combination of knolwedge gained from research/science and how the ACTUAL patient was responding to various treatment.

Of course much of this treatment was not covered by insurance- which I suppose is one of the reasons why "evidence-based medicine" is such a dangerous phrase. It's real goal is cost containment, but to the average person who has never faced a serious, challenging health problem like Lyme it sounds all too reasonable and obvious an answer to the health care crisis.

I disguise the indentiy of my patients and always get permission to discus their cases. Facts are altered. Some cases are a composite of several patients. I do not violate HIPPA laws.I do not appreciate personal attacks for political reasons.I have no interest in politis which has entered the fray here. My name is not hard to find.My motive is to further knowledge and science as we all learn about it.

By the contrary when I read this blog it seems like it is about me who he is writing about. Every case relates to mine, every information given helps me, guides me, throws some light to understanding this confusing, painful, absurd disease. Each post is a gift I unwrap with gratitude!

Many sick like me share this I'm saying. In their name and mine, I just can beg the Doctor to keep on posting his ideas, his experiences, his opinions, his medical concepts, his knowledge and his doubts, for the good of medicine, of science and us!

Is the Fallon you mention the Fallon running the Lyme Disease Research group at Columbia? If so, they seem to have done quite a bit of "test tube science" there. Have you looked at their website? What do you think?They're still quite conservative but I think their -quite recent- existence proves a shift in Lyme disease research, at least a recognition that what doctors thought of as definitive answers are not at all. I fear I do not really understand what EBM is, so maybe my comment is only peripherally related. Basically though, I think things are slowly moving for the best, although at an incredibly frustrating pace.

Hello fellow curious person in the healing arts and sciences. I am, or rather, was an FNP with over 20 years of clinical practice,MA in Biology, JD (Doctorate in Law). Mostly soup to nuts. 11 years ago I noticed a target rash and took my leg in to Kaiser for confirmation. Lyme. Never saw a tick, but got Doxycycline for, I believe, 7 to 10 days. Began having problems 5 years later when, among other things, I was raising my sons alone, full time work, and law school at nite. Diagnosis was Fibromyalgia. I noticed that it was getting worse last June and finally questioned the dx. The Infectious disease specialist in my branch of KP began his conversation over the phone with me "I am a member of IDSA." I had been in bed for 2 years, after retiring disabled. I managed to get him to give me 28 days of Keflex. within 2 weeks I recognized some of the old me. Energy gradually returning, less pain around my face, some cognitive improvement and finally I was able to take my mini RV and go for adventures. About a week ago my energy started to wane. I am so disabled now that in my last email to my Kaiser doc, I cried great salty tears while I typed. In his reply to my begging him to start Rocephin, or at least refer me to someone in the KP system that would do something, he told me that he had mailed me something from Lancet. Today I received the mail. It was entitled "Personal View- Antiscience and ethical concerns associated with advocacy of Lyme disease." As I read on I realized that he now has identified me as part of a group of "antiscience" persons that deny"the viral cause of AIDS, benefits of vaccines, and supports dangerous alternative practices."It felt like a personal slap in the face. I felt dehumanized, patronized. Granted, he has had to stretch his medical practices to allow me to tell him what was wrong with me all these years. I'm so angry that I want to start a class action suit against KP for negligence, refusal to recognize chronic Lyme disease, and therefore, refusal to treat any persons inadequately treated for Lyme. What evidence based treatment guidelines do not take into account is that Lyme is a disease that requires a clinical(manifestations of both signs and symptoms of disease) diagnosis and expert clinical judgment.